Autoimmume/Inflammatory Syndrome Induced by Adjuvants (ASIA Syndrome) Caused by Polypropylene Mesh Implantation - a Pilot Study for Diagnostics and Treatment

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test, Procedure
Study Type: Observational
SUMMARY

In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients \>18 years of age and written informed consent obtained;

• Suspected ASIA syndrome after elective hernia, pelvic organ prolapse (POP) surgery, or stress urinary incontinence (SUI) repair, defined as three major ASIA criteria (Table 1), of which the exposure to an external stimulus (PP mesh) is one;

• ASIA complaints evolved after the implantation of PP mesh and were not present before the surgical repair.

Locations
Other Locations
Netherlands
Amsterdam UMC
NOT_YET_RECRUITING
Amsterdam
Maastricht University Medical Centre
ACTIVE_NOT_RECRUITING
Maastricht
Maxima Medical Centre
RECRUITING
Veldhoven
Contact Information
Primary
Willem AR Zwaans, MD PhD
willem.zwaans@mmc.nl
+31408888550
Time Frame
Start Date: 2022-05-09
Estimated Completion Date: 2025-05
Participants
Target number of participants: 50
Treatments
Included patients
Patients included with index operation that are referred to a participating outpatient clinic and who present with ASIA Syndrome-like complaints occurring after PP implant placement.
Sponsors
Collaborators: Amsterdam UMC, Maastricht University Medical Center
Leads: Maxima Medical Center

This content was sourced from clinicaltrials.gov